# K961638: Medilog Mpa-S

- Pathway: 510(k) (Traditional)
- Applicant: Oxford Instruments Medical Systems
- Decided: Jan 17, 1997 after 263 days
- Product code: OLV (Standard Polysomnograph With Electroencephalograph)
- Device class: 2
- Regulation: 21 CFR 882.1400
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
No later device cites it as a predicate yet.
0 of 1 device in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. FDA’s file for it is a 510(k) statement, which names no predicate.

## Indications for use
Recording of a physiological signals (single channel of EEG, and or recording of ECG signals at 64 Hz) that are required to aid in the diagnoses of sleep related disorders.

Source page: https://510kreport.com/device/K961638
Methodology: https://510kreport.com/methodology